BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TOTALYS SLIDEPREP

    MDR report key: 22951791 · Received September 3, 2025

    Report

    Report Number
    3008007472-2025-00012
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 10, 2025
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    00382904913090
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR KIT 491309 LOT 4241092 HAVING AN EXPIRED SUBCOMPONENT, 080-11025-01 LOT 5112810. THE KIT EXPIRATION DATE IS 2026-07-03 AND THE SUBCOMPONENT IN THE PICTURE PROVIDED BY THE CUSTOMER HAS AN EXPIRATION DATE OF 2025-03. MATERIAL 491309 IS PRODUCED AT THE BD MEBANE, NC FACILITY BY WAY OF A MANUAL PACK OUT PROCESS IN THE KITTING CELL. DHR REVIEW FOR THE LOT WAS PERFORMED WHICH IDENTIFIED THAT THE PRODUCTION ORDER OF KIT 491309 CONTAINED AN EXPIRATION DATE OF 2026-07-03. REVIEW OF THE DHR BILL OF MATERIALS (BOM) INDICATES THAT SUBCOMPONENT 080-11025-01 LOT NUMBERS 5164943 AND 5171698 WERE USED IN THE MANUFACTURE OF 491309 LOT 4241092. THE DHR BOM DID NOT INDICATE USE OF 080-11025-01 LOT 5112810. ANALYSIS OF ERP TRANSACTIONS DETERMINED THAT ALL INVENTORY OF 080-11025-01 LOT 5112810 WAS CONSUMED ON OR BEFORE 07AUG2024. THE MANUFACTURING DATE OF KIT 491309 LOT 4241092 IS 04SEP2024, THEREFORE, THERE WOULD HAVE BEEN NO REMAINING INVENTORY OF THE SUBCOMPONENT INDICATED IN THE CUSTOMER COMPLAINT. BASED UPON THE ANALYSIS OF THE PRODUCTION RECORDS, THE COMPLAINT IS NOT CONFIRMED. BD MEBANE DOES NOT KEEP RETAINS AT THE KIT LEVEL, THEREFORE NO RETAIN ANALYSIS COULD BE PERFORMED. A SAMPLE WAS NOT RETURNED BUT PICTURES WERE PROVIDED. THE PICTURES SHOW SUBCOMPONENT 080-11025-01 LOT 5112810 WITH AN EXPIRATION DATE OF 2025-03. THE PICTURES DO NOT OBJECTIVELY CONFIRM THE PRESENCE OF 080-11025-01 LOT 5112810 WITHIN KIT 491309 LOT 4241092. A TWELVE-MONTH COMPLAINT REVIEW FOR EXPIRATION DATING ISSUES WAS PERFORMED AND DID NOT IDENTIFY PREVIOUS COMPLAINTS. MONTHLY COMPLAINT TRENDING IS PERFORMED TO DETERMINE IF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS REQUIRED, AND TREND AND RISK LEVELS INDICATE THAT A CAPA IS NOT CURRENTLY REQUIRED. BD WILL CONTINUE TO PERFORM REGULAR TRENDING TO DETERMINE IF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS REQUIRED IN THE FUTURE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING KIT TOTALYS SLIDE PREP 480 TEST JIS, THE TRANSFER TIP COMPONENTS HAD AN EARLIER EXPIRATION DATE THAN THE OVERALL KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733845 BD TOTALYS SLIDEPREP PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 4241092 00382904913090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown